FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DEFLECTING WIRE GRASPER

K Number: K903707 · Decision Sep 26, 1990
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
23
Applicant Total
190
Review Days
42

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Basic Information

Device Name
DEFLECTING WIRE GRASPER
K Number
K903707
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
884.4530
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Applicant
Cook, Inc.
Date Received
August 15, 1990
Decision Date
September 26, 1990
Product Code
HCZ
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HCZ Forceps, Surgical, Gynecological

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K132592 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K133597 CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K131772 CANTATA(R) 2.9 MICROCATHETER
K131204 ADVANCE CS CORONARY SINUS INFUSION CATHETER
K133634 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K132020 ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K131201 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131206 COOK CERVICAL RIPENING BALLOON
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